Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and

FDA device recall Z-1471-2014 · posted 2014-04-23 · Terminated

Recall details

Recalling firm

HeartWare Inc

Reason for recall

The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.

Action taken

HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their hospitals and doctors on December 12, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. For already implanted patients, arrange a follow up visit at the earliest convenience to check patient's driveline connector. They were asked to sign and return the Acknowledgement Form to HeartWare. For questions, contact your HeartWare Representative or HeartWare Customer Service at 1-877-367-4823.

Root cause

Process control

Status

Terminated

Product code

DSQ

Quantity affected

4,586

Distribution

Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Ar

Date initiated

2013-12-06

Date posted

2014-04-23

Date terminated

2016-11-03

Location

Miami Lakes, FL